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    Summary
    EudraCT Number:2012-004951-35
    Sponsor's Protocol Code Number:DISOBBED-12
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-004951-35
    A.3Full title of the trial
    Disulfiram, obesity and binge eating disorder
    Disulfiram, obesita' e binge eating disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Disulfiram in the treatment of eating disorders
    Disulfiram per il trattamenti dei disturbi della condotta alimentare
    A.4.1Sponsor's protocol code numberDISOBBED-12
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDipartimento di Scienze Biomediche
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Scienze Biomediche
    B.5.2Functional name of contact pointSezione di Neuroscienze
    B.5.3 Address:
    B.5.3.1Street AddressSS 554, Km 4,5
    B.5.3.2Town/ cityMonserrato
    B.5.3.3Post code09042
    B.5.3.4CountryItaly
    B.5.4Telephone number070 6754325
    B.5.6E-mailagabio@unica.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ETILTOX*30CPR 200MG
    D.2.1.1.2Name of the Marketing Authorisation holderA.F.O.M. DIPENDENZE Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDISULFIRAM
    D.3.9.1CAS number 97-77-8
    D.3.9.4EV Substance CodeSUB06326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity and binge eating disorder
    Obesità e binge eating disorder
    E.1.1.1Medical condition in easily understood language
    Obesity and binge eating disorder
    Obesità e binge eating disorder
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and handling of disulfiram in the treatment of obese patients with binge eating disorder
    Valutare l’efficacia e la maneggevolezza del disulfiram nel trattamento di pazienti obesi affetti da binge eating disorder
    E.2.2Secondary objectives of the trial
    -
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) obesity (BMI ≥ 30); 2) diagnosis of BED according to the diagnostic criteria of the DSM-IV-TR (APA, 2000); 3) aged between 18 and 65 years; 4) residence throughout the period of the study in a location that allows compliance with scheduled visits; 5) be able to discernment, to understand the purposes of the study, provide appropriate behaviors for its implementation, agree on the protocol on the participation in the study and sign an informed consent 6) normal liver and kidney function demonstrated by blood tests performed within the 3 months prior to enrollment (such as complete blood count, blood glucose, BUN, creatinine, ALT, AST, GGT, serum protein)
    1) obesità (BMI≥30); 2) diagnosi di BED in accordo ai criteri diagnostici del DSM-IV-TR (APA, 2000); 3) età compresa tra i 18 ed i 65 anni; 4) residenza per tutto il periodo dello studio in una località che consenta il rispetto delle visite programmate; 5) essere in grado di intendere e di volere, di comprendere gli scopi dello studio, fornire comportamenti adeguati alla sua realizzazione, concordare sul protocollo, sulla partecipazione allo studio e firmare un consenso informato 6) normale funzionalità epatica e renale attestata da esami ematochimici effettuati nell’arco dei 3 mesi precedenti l’arruolamento (quali emocromo, glicemia, azotemia, creatinina, ALT, AST, GGT, proteinemia)
    E.4Principal exclusion criteria
    1) Diagnosis of dependence and / or current or lifetime alcohol abuse according to the DSM-IV-TR; 2) diagnosis of a psychotic disorder current or lifetime according to the diagnostic criteria of the DSM-IV-TR; 3) a diagnosis of other medical disorders (severe heart disease, diabetes, cirrhosis, hypothyroidism and / or renal dysfunction) or psychiatric disorder (severe mood disorders, suicidal ideation current or past) that, based on medical judgment, may constitute a danger to the participation of the patient in the study or limit compliance; 4) for women of childbearing potential: pregnant, lactating or non-use of contraceptive methods (oral contraceptives or depot, barrier methods such as condoms or spiral); 5) hypersensitivity to disulfiram; 6) start of a psychotherapy treatment for BED less than 3 months; 7) start of drug therapy with psychoactive drugs (antidepressants, anxiolytics, etc..) By a period of less than one month
    1) Diagnosi di dipendenza e/o abuso di alcol attuale o lifetime in accordo ai criteri diagnostici del DSM-IV-TR; 2) diagnosi di un disturbo psicotico attuale o lifetime in accordo ai criteri diagnostici del DSM-IV-TR; 3) diagnosi di un altro disturbo medico (gravi cardiopatie, diabete, cirrosi, ipotiroidismo e/o nefropatie) o psichiatrico (gravi disturbi dell’umore, ideazione suicidiaria attuale o pregressa) che, in base al giudizio medico, possa costituire un pericolo per la partecipazione della paziente allo studio o limitarne la compliance; 4) per le donne in età fertile: stato di gravidanza, allattamento o mancato utilizzo di metodi contraccettivi (contraccettivi orali o depot, metodi di barriera come spirale o preservativo); 5) ipersensibilità accertata verso il disulfiram; 6) inizio di una psicoterapia terapia per il BED da meno di 3 mesi; 7) inizio di una terapia farmacologica con farmaci psicoattivi (antidepressivi, ansiolitici etc.) da un periodo inferiore a 1 mese
    E.5 End points
    E.5.1Primary end point(s)
    1) frequency of episodes of binge; 2) body weight; 3) possible occurrence of side effects; 4) severity of craving for food; 5) quality of life
    1) frequenza degli episodi di abbuffata; 2) peso corporeo; 3) eventuale comparsa di effetti collaterali; 4) severità del craving per il cibo; 5) qualità della vita
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 settimane
    E.5.2Secondary end point(s)
    -
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    -
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The researcher must provide appropriate medical care to all patients leaving the study or direct them to appropriate therapy
    Il ricercatore dovrà fornire l'assistenza medica necessaria a tutti i pazienti che lasciano lo studio o indirizzarli per una terapia appropriata
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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